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Clinical Trials/CTRI/2025/10/096503
CTRI/2025/10/096503Not yet recruitingPhase 4

Epidermal growth factor dressing in comparison to Collagen sheet dressing for Skin graft donor site wound

Aarupadai veedu medical college1 site in 1 country60 target enrollmentStarted: November 7, 2025Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
Epidermal growth factor dressing is better than Collagen sheet dressing in aspects of Wound healing time, Scar quality, Low chance of Surgical site infection.

Study Overview

Brief Summary

After the clearance from the IRC and IEC, sampling of patients for Epidermal Growth Factor and Collagen sheet dressing done by Group Allocation concealment method during the study period mentioned, fulfilling the inclusion and exclusion criteria already listed above will be recruited for the study, after obtaining informed consent. The nature, purpose, and the roles in the study will be explained in detailed, including the information that their non-participation in the study would not affect the quality of the treatment that they are to receive and that they are free exit the study at any time. After assuring that their response would remain confidential, an informed written consent for the same shall be obtained from the all participants.

Patients will be randomized into two groups. This is done by Group Allocation Concealment Method (i.e) Patient has been separated randomly into two groups by single blinding technique as the investigator alone knows which patient is in which group.

Collagen sheet dressing and Epidermal Growth Factor dressing will be performed for both the groups. In one group Collagen sheet dressing and in the other group Epidermal Growth Factor dressing will be performed. Duration of wound healing, post operative complications has been evaluated. Donor site dressing will be opened only after 14 days of surgery. On Post operative day 2, 4 and 6 , I will measure pain of the patients using Pain score scale. On Post operative day 14, 1 st look of the donor site wound will be done and 2 nd look will be done on post op day 21 based on scar pigmentation (Normal /Hypopigmentation /Hyperpigmentation), scab formation, infection.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All patients undergoing split thickness skin grafting were included in the study.

Exclusion Criteria

  • Hypersensitivity to collagen Infected donor site wound Uncontrolled diabetes Severe anemia and Hypoproteinemia Immunocompromised patients Mentally ill patients Malignancy, local irradiation Collagen vascular disease Patient refusal.

Outcomes

Primary Outcomes

Epidermal growth factor dressing is better than Collagen sheet dressing in aspects of Wound healing time, Scar quality, Low chance of Surgical site infection.

Time Frame: Assessing donor site wound on post operative day 14 and 21 for wound characteristics

But, Collagen sheet dressing is better in terms of Pain in comparison with Epidermal growth factor local applicantion.

Time Frame: Assessing donor site wound on post operative day 14 and 21 for wound characteristics

Secondary Outcomes

  • Assessment of pain over donor site wound on comparing epidermal growth factor and collagen sheet dressing(Post operative day 2, 4,6)

Investigators

Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Amirtharaj N

Aarupadai veedu medical college

Study Sites (1)

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